Modern healthcare has changed dramatically over the past year. In particular, mobile health applications saw an increased adoption rate among smartphone users. Millions of people are now using one or more apps as part of their daily health routine – whether it is tracking workouts or reading notes from a doctor’s office visit. Some apps are less task-oriented and more “Internet of Things”-oriented, helping patients do things like breathe.
For example, the Instant Heart Rate application had more than 4 million downloads as of mid-2014. In response to this trend, as well as the number of mobile apps designed for healthcare professionals, the Food and Drug Administration (FDA) has begun regulating mobile apps as medical devices.
Last week, the FDA released its updated guidance for medical mobile apps (MMA). Taking a risk-based approach, the FDA will focus on apps that could pose a risk to a patient’s safety or that function as a “medical device,” defined as those that:
1. Are intended to be used as an accessory to a regulated medical device—including displays of patient-specific data, such as an app that allows a healthcare professional to make a specific diagnosis or treatment decision directly from a Picture Archiving and Communication System (PACS) or remote display of data from bedside monitors, or an app that provides the ability to control medical devices, such as the inflation or deflation of a blood pressure pump; or
2. Transform a mobile platform into a regulated medical device—e.g., an app that turns a smartphone into an electrocardiography (ECG) machine to measure ECG signals, or an app that uses the smartphone’s built in accelerometer to collect motion information to monitor sleep apnea; or
3. Perform patient-specific analysis and provide diagnosis or treatment recommendations. These apps are akin to the types of software devices that have been previously cleared or approved, such as radiation therapy treatment planning software.
While the FDA is charged with regulating these apps and letting customers know which of them are safe or not, other apps that fall outside of the purview of the FDA may still be harmful. For example, this “medical” app was leaking private user information. Monitoring for these bad apps that may be leveraging your brand is key to protecting your brand and organization. To learn more about mobile security trends we predict for 2015, attend our webinar or view the on-demand version.